Overview

This trial is active, not recruiting.

Condition influenza h1n1
Sponsor The University Clinic of Pulmonary and Allergic Diseases Golnik
Start date November 2009
Trial size 15 participants
Trial identifier NCT01178918, KOPA-H1N1-01

Summary

This is a prospective observational study with recruitment of healthy volunteers from consecutive recipients of H1N1 influenza vaccine at the University Clinic of Respiratory and Allergic Diseases, Golnik, Slovenia.

The purpose of this study is to evaluate certain safety aspects of adjuvanted influenza H1N1 vaccines.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm

Primary Outcomes

Measure
T Cell Immune responce monitoring after Influenza A (H1N1) AS03-Adjuvanted Vaccination
time frame: At 3 weeks after vaccination
T Cell Immune responce monitoring after Influenza A (H1N1) AS03-Adjuvanted Vaccination
time frame: At 11 weeks after vaccination.

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Recipients of H1N1 influenza vaccine. - Healthy individuals with no signs of influenza or other infectious disease. Exclusion Criteria: - Signs of influenza or other infectious disease in 1 month before study participation.

Additional Information

Official title Enhanced Non-Specific T Lymphocytes Response to Influenza A (H1N1) AS03-Adjuvanted Vaccine
Trial information was received from ClinicalTrials.gov and was last updated in August 2010.
Information provided to ClinicalTrials.gov by The University Clinic of Pulmonary and Allergic Diseases Golnik.